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Pharma and Biotech
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Pharma and Biotech
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Pharma and Biotech
Pharma and Biotech
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The development of Highly Potent Active Pharmaceutical Ingredients (HPAPI) is steadily increasing. And no wonder: these individually tailored active ingredients are achieving great success in oncology, for example.For pharmaceutical companies, processing and filling highly potent drugs is full of challenges: Small volumes and quantities demand a great containment effort. We provide you with all-round support for these tasks, thanks to our holistic process and complete turnkey systems.
Processing highly potent APIs requires robust safety measures for both people and products. Room and machine must form a functioning overall system to ensure safety. We provide comprehensive advice on room, pressure and wastewater concepts, as well as on decontamination and containment. It is also important to take a detailed look at the interfaces between the filling line, freeze-drying and isolator. Plan your fully developed complete system together with us.
Processing highly potent APIs requires robust safety measures for both people and products. Room and machine must form a functioning overall system to ensure safety. We provide comprehensive advice on room, pressure and wastewater concepts, as well as on decontamination and containment. It is also important to take a detailed look at the interfaces between the filling line, freeze-drying and isolator. Plan your fully developed complete system together with us.
For the production of biologics and small molecules for oncology, the French pharmaceutical company Servier relies on a flexible multiuse turnkey system from Optima, including a freeze dryer and isolator for highly potent APIs.
Besides the criteria of the integrated design and project management of the filling system, aseptic isolator and freeze dryer, we were convinced by the state-of-the-art technology of the flexible line and its '4.0 compliance'.
Choose from different options to find the right cleaning concept for your easily accessible system. A simulation of your cleaning processes helps to arrive at the right design for you. Wash down can be either manual or semi-automatic. Alternatively, we can position automatic cleaning nozzles - completely individually according to your requirements.
The freeze-drying design also adapts to your highly potent APIs. First, safe and gentle handling of your containers during loading and unloading avoids any contamination. Second, filters in the suction line of the vacuum system safely discharge the highly potent exhaust air. Third, the system neutralizes potentially highly potent substances and, fourth, it uses vacuum pumps that can be flushed and decontaminated.
When systems for highly potent substances are designed as a complete system, human and product safety can be maximized.
When processing complex highly potent APIs, interfaces play an important role in the system. That's where the turnkey principle comes in. A comprehensive system concept in which all process steps are seamlessly interlinked. Especially in systems for highly potent APIs, where many functions are directly related.
Our CSPE (Comprehensive Scientific Process Engineering) is a breakthrough approach that reduces the time to system readiness. Measures include digital engineering, simulations, virtual reality and integrated FAT (Factory Acceptance Test).
Discover CSPEReal-life examples best show the advantages offered by Optima's sophisticated solutions. Explore our success stories.
